A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer

Summary

This is a first-in-human (FIH), Phase 1/2a, multi center, open-label, single treatment, dose escalation and expansion study designed to determine the safety and tolerability of STM-416 in patients with bladder cancer.

Eligibility

Inclusion Criteria:

1. Are aged 18 years or older;
2. Have a history of pathologically confirmed high-grade Ta or T1 NMIBC without CIS who have completed SOC previously, with recurrent papillary disease seen on cystoscopy, and who are undergoing TURBT without perioperative intravesical chemotherapy;
3. Are considered high risk for recurrence;
4. Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2;
5. Have adequate organ and marrow function as defined below:

   * Hemoglobin 9.0 g/dL;
   * Absolute neutrophil count 1.5 × 109/L (1500 per mm3);
   * Platelet count 75 × 109/L (75,000 per mm3);
   * Serum bilirubin 1.5 × institutional upper limit of normal (ULN);
   * AST (serum glutamic-oxaloacetic transaminase)/ALT (serum glutamic-pyruvic transaminase) 2.5 × institutional ULN; and
   * Creatinine CL 60 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine CL: Males: Creatinine CL (mL/min) = Weight (kg) × (140 - Age)/72 × serum creatinine (mg/dL); or Females: Creatinine CL (mL/min) = Weight (kg) × (140 - Age) × 0.85/72 × serum creatinine (mg/dL).

Exclusion Criteria:

1. Have a history of CIS or MIBC;
2. Are receiving any other investigational agents;
3. Have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to resiquimod (R848), or excipients used in STM-416 including poloxamer 407 and sodium hyaluronate;
4. Have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

   Urinary tract infections are not exclusionary unless they are NCI-CTCAE Grade 3 or higher;
5. Are a woman of childbearing potential regardless of contraceptive use; Note: Women of childbearing potential are only to be excluded in Phase 1 and Phase 2a to avoid bias due to the low prevalence of NMIBC in this population. However, they will be included in subsequent Phase 2/3 studies.

Conditions2

Locations10 sites

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